Actively Recruiting
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With Large B-cell Lymphoma in Partial Response After CAR T-cell Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating loncastuximab tesirine (called "lonca") as a consolidation therapy for patients with large B-cell lymphoma (LBCL) that has come back or not responded after CAR T-cell therapy. This Phase II study aims to see if lonca can help patients who have achieved a partial response (PR) after CAR T-cell therapy. The study also looks at the safety, tolerability, and biological effects of lonca, including biomarkers of response and resistance. Participants will receive loncastuximab tesirine through an intravenous (IV) infusion. The treatment is given after patients have shown partial response at least 30 days following CAR T-cell therapy, with no additional anti-tumor treatments received since then except palliative radiotherapy. The study is designed to assess lonca as a consolidation strategy in this specific patient group, with dosing and administration details managed by the research team. During the study, participants will be monitored closely with various assessments including blood tests to check blood counts, liver and kidney function, and cardiac function. Researchers will measure how many patients convert from partial response to complete response over the study period, which may last up to one year. Safety and tolerability will also be tracked throughout the trial. Patients will have regular visits to evaluate their health status and response to lonca, ensuring careful follow-up during and after the treatment period.
CONDITIONS
Brief Title
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas, or high-grade B-cell lymphoma
- Received standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product outside of a clinical trial
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Achieved partial response according to Lugano 2014 criteria at least 30 days after CAR T-cell therapy
- At least 30 days elapsed since CAR T-cell therapy infusion
- No evidence of CD19 expression after CAR T-cell therapy infusion
- No additional anti-tumoral therapy after CAR T-cell therapy except palliative radiotherapy
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L without growth factor support for 3 days prior to screening
- Platelet count ≥ 50 x 10^9/L without transfusion for 3 days prior to screening
- Creatinine clearance ≥ 30 mL/min
- Serum ALT or AST ≤ 2.5 times upper limit of normal
- Total bilirubin ≤ 2 mg/dL (except for Gilbert's syndrome)
- Cardiac ejection fraction ≥ 45% with no significant pericardial effusion
- Baseline oxygen saturation > 92% on room air
- No evidence or suspicion of lymphoma involving the central nervous system
- Females of childbearing potential must have a negative pregnancy test
- Resolution of any previous cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) to grade 0
You will not qualify if you...
- Clinically significant third space fluid accumulation requiring drainage or causing shortness of breath
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ unless disease free for at least 12 months
- History of Richter's transformation of chronic lymphocytic leukemia
- Treatment with CAR T-cell therapy on a clinical trial immediately before enrollment
- Prior treatment with loncastuximab tesirine
- Uncontrolled or IV antimicrobial-requiring infections; simple UTI or uncomplicated bacterial pharyngitis allowed if responding to treatment
- Known history of HIV, hepatitis B, or hepatitis C unless viral load is undetectable
- Active cardiac atrial or ventricular lymphoma involvement
- Recent significant cardiac disease within 12 months
- Primary immunodeficiency
- Autoimmune disease causing end organ injury or requiring systemic immunosuppression within last 2 years
- Recent deep vein thrombosis or pulmonary embolism within 1 month
- Any medical condition interfering with safety or efficacy assessment
- History of severe immediate hypersensitivity to study agents
- Pregnant or breastfeeding women of childbearing potential
- Not willing to use birth control methods as required after treatment
- Unlikely to complete study visits or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment as per protocol (not specified)
Participants receive Loncastuximab Tesirine by vein as consolidation therapy after CAR T-cell therapy.
Visits as needed for IV administration and monitoring (exact schedule not specified)
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paolo Strati, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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